Reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited documentation, no information on purity.

Data source

Reference

Reference Type:

publication

Title:

Controlled Exposures Of Human Volunteers To Sulfate Aerosols. Health Effects And Aerosol Characterization.

Author:

Avol EL et al

Year:

1979

Bibliographic source:

Am Rev Respiratory Disease 120: 319-327.

Materials and methods

Type of study / information:

controlled study

Endpoint addressed:

acute toxicity: inhalation

Principles of method if other than guideline:

Both healthy and asthmatic adult men were exposed for a 2 h period to ammonium sulphate under controlled conditions (particle size distribution and concentration). Lung function tests were performed.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium sulphate

EC Number:

231-984-1

EC Name:

Ammonium sulphate

Cas Number:

7783-20-2

Molecular formula:

H8N2O4S

IUPAC Name:

diammonium sulfate

Details on test material:

- Name of test material (as cited in study report): ammonium sulphate
No further data

Method

Exposure assessment:

measured

Results and discussion

Results:

No evidence of an adverse health effect on healthy, sensitive and asthmatic adult men was found after 2-hour multiple day exposures to  "worst case" ambient concentrations (0.1 to 0.3 mg/m³ of ammonium sulphate with a MMAD of 0.3-0.6 µm and a relative humidity ranging between 40 and 85% in the different experiments).

Any other information on results incl. tables

Five normal subjects, 5 sensitive subjects and 6 asthmatics were studied.
Neither significant functional changes nor consistent changes in symptom score were found in the normal group at low humidity. At high humidity, significant variation in forced expiratory measures was detected, but the changes were small in magnitude, and the performance tended to be better on exposure days than on control days.
The sensitive group displayed small but significant variations in pulmonary function at both low and high humidity; once again, these appeared to be occurrences not related to the aerosols. On the last exposure day of the high-humidity studies, the sensitive subjects reported a significant increase in total symptom score. Examination of the individual symptoms reports indicated that his was due to increased fatigue.
The asthmatic subjects showed a marginal decrease in the slope of the alveolar plateau of the single breath N2 washout between the beginning and the end of exposure, both with clean air and with exposure to ammonium sulphate. In the absence of other changes in function, this would be interpreted as representing an increase in uniformity of ventilation distribution within the bungs, i.e., an improvement in function. Symptom scores and other pulmonary function results did not indicate any increase toward dysfunction.

For details, see attached files, tables 2 and 3

Conclusion
In conclusion, no evidence of an adverse health effect on healthy, sensitive and asthmatic adult men was found after 2 -hour multiple day exposures to  "worst case" ambient concentrations (0.1 to 0.3 mg/m³ of ammonium sulphate with a MMAD of 0.3-0.6 µm and a relative humidity ranging between 40 and 85% in the different experiments).